Rapid Micro Methods News

Our news pages will keep you informed of press releases and news articles on RMM technologies, updates from technology suppliers, reviews of recent publications and presentations, and what's changing in the world of rapid methods. You can also follow our news posts on Twitter, Facebook, LinkedIn and RSS.

Tuesday, February 28, 2017

Escherichia coli is the most important indicator organism for fecal contamination of drinking water, food and beverages. It can be reliably detected with growth media that contain substrates for beta-glucuronidase, an enzyme that occurs almost exclusively in E. coli. Today 4-Methylumbelliferyl beta-D-glucuronide (MUG) is recommended in international guidelines as a fluorogenic substrate for E. coli detection. In standard assays bacteria culture media are supplemented with MUG and incubated at 37°C. In the presence of E. coli a blue fluorescence can be detected under UV light after 24 hours. The detection limit of such assays is typically 10 CFU/ml.

Biosynth recently launched RUG™, a new substrate for beta-glucuronidase that is based on Resorufin - one of the most intensely fluorescent materials known today. RUG™ (Resorufin-beta-D-glucuronic acid methyl ester) is a highly sensitive chromogenic and fluorogenic indicator for E. coli. After removal of the methyl ester group by unspecific hydrolysis, the product is cleaved by beta-glucuronidase in liquid media and yields an intense pink color. Red fluorescence is obtained upon excitation at 560-570 nm. RUG™ is 5 to 10 times more sensitive than MUG and fluorescence develops in liquid culture media in less than half the time - after only 10 hours. These findings suggest the usage of RUG™ in place of MUG for the development of fast fluorescence E. coli assays.

As RUG™ generates a strong pink coloration that can be detected by the naked eye it further opens possibilities for the use of RUG™ in situations where fluorescence detection is not possible. Field studies are currently being carried out under the auspices of the WHO using RUG™ to test drinking water in hot climates. As RUG™ is chemically stable, prepared dry media containing RUG™ may be stored at ambient temperature for several months.

Tuesday, February 21, 2017

The company's GenoAmp Real-Time PCR Leptospirosis is a multiplex PCR kit that detects pathogenic Leptospirosis in human and environmental samples. It is designed for the fast and early screening of Leptospirosis using a single reaction.

"The kit is intended for rapid and early diagnosis in clinical samples such as blood and urine, as well as for use in environmental surveillance," said the company in a statement. "The kit can be used to test for the disease within the first 3-7 days after initial symptoms, which offers a huge advantage over some of the tests currently available, which can only detect the disease after 7 days." Early detection is critical for better treatment outcome, before the progression of the disease.

Leptospirosis is transmitted by the urine of an infected animal and is contagious as long as the urine is still moist. Leptospiral infection in humans causes a range of symptoms with some infected persons showing no symptoms at all. The disease begins suddenly with fever accompanied by chills, intense headache, muscle ache, abdominal pain, red eye, and occasionally a skin rash. There are two phases to the disease. The first symptoms appear after a period of incubation of 7-12 days. The first phase (acute or septic phase) ends after 3-7 days of illness. The disappearance of symptoms coincides with the appearance of antibodies against Leptospira in the bloodstream.

A University of Florida Institute of Food and Agricultural Sciences entomologist will use a $200,000 grant from the Florida Department of Health to improve tests for the detection of the Zika virus.

In 2016, Florida saw 1,272 cases of Zika, which is usually associated with mild symptoms, although severe symptoms may also occur, including Guillain-Barré syndrome and birth defects in babies, according to the U.S. Centers for Disease Control and Prevention. Of those, 256 were locally acquired. So far this year, four more cases have been reported, all travel-related.

Barry Alto, a UF/IFAS assistant professor of medical entomology, said scientists need better diagnostic tools to detect Zika virus to meet challenges to public health. He is working with collaborator Steven Benner at Firebird Biomolecular Sciences LLC to develop methods they hope should take about an hour – far less time than current testing methods. Existing methods require specialized equipment and highly trained personnel, so samples must be transported to specialized laboratory facilities to perform the tests.

Alto will work with Benner, a former UF chemistry distinguished professor and founder of Gainesville-based Firebird Biomolecular Sciences LLC. Together, they plan to develop an inexpensive, user-friendly and rapid diagnostic Zika test.

“The project has the potential to impact the health of Floridians,” said Alto, a faculty member at the UF/IFAS Florida Medical Entomology Laboratory in Vero Beach, Florida. “It can improve surveillance by advanced warning of Zika transmission through tests of mosquito samples, allow for strategic deployment of limited resources by mosquito control to reduce incidence and prevalence of Zika and improve health care to Floridians by rapid diagnosis in human samples.”

Alto and Benner will combine current Zika-detection techniques with innovations in synthetic biology. Those include AEGIS (artificially expanded genetic information system), which allows pathogen nucleic acid-targeted tests to be ultra clean, and SAMRS (self-avoiding molecular recognition systems) that allow ease of multiplexing of pathogen nucleic acid-targeted test so other arboviruses can be detected in addition to Zika virus.

During the one-year project, scientists will travel to Florida’s public health service labs to demonstrate the technique and to test their method to detect Zika and other arboviruses.

“We are interested in getting feedback from individuals involved in mosquito control and public health,” Alto said.

Zika can be transmitted when a female mosquito, most likely an infected Aedes aegypti, bites a human. The virus can cause birth defects, including microcephaly, or a smaller-than-normal head, in babies as well as Guillain-Barré syndrome, a condition in which the immune system attacks your nervous system. Currently there is no vaccine available for Zika virus.

To try to avoid mosquito bites, UF/IFAS Extension faculty urge people to stay indoors or wear long-sleeve shirts and pants if they’re outdoors, especially during the day, when mosquitoes that might transmit the Zika virus are more likely to bite. They also urge people to apply mosquito repellent containing DEET and remove mosquito-breeding habitats by removing water from containers because that’s where mosquitoes lay their eggs and the immature stages develop.

Royal Philips, a leader in HealthTech, and Diagnostics Development, a P&M Venge company spin-off from Uppsala University (Sweden), have demonstrated a proof-of-concept for the rapid and reliable detection of bacterial infection. The test is based on Philips’ Minicare I-20 handheld diagnostics platform and detects the human neutrophil lipocalin (HNL) biomarker in a single ‘finger-prick’ drop of blood. In recognition of the test’s ability to distinguish between acute bacterial and viral infections, and thereby mitigate the unnecessary use of antibiotics, the two companies were awarded the European Union ‘Horizon Prize – Better Use of Antibiotics’ during a special award ceremony on the evening of February 6, 2017.

Antimicrobial agents – such as antibiotics – have dramatically reduced the number of deaths from infectious diseases since their introduction 70 years ago. However, through their overuse and misuse, many micro-organisms have become resistant to them. It is estimated that each year this growing antimicrobial resistance (AMR) causes around 25,000 deaths and accounts for over EUR 1.5 billion in healthcare costs and productivity losses in Europe alone, making it one of the greatest challenges facing society today. To boost development and bring new and innovative players to AMR research, the EU issued a prize for the individual or team that most effectively meets the following challenge: ”to develop a rapid test that will allow healthcare providers to distinguish at the point of care between patients with upper respiratory tract infections that require antibiotics and those that can be treated safely without antibiotics”.

“This prize is a great recognition of how collaboration can lead to innovative diagnostic solutions that improve patient care,” said Marcel van Kasteel, CEO of Handheld Diagnostics at Philips. “The HNL program for detection of bacterial infections perfectly fits with our ‘open platform’ strategy of bringing innovative biomarker content onto the Minicare I-20 platform in order to offer healthcare professionals a panel of relevant tests for acute settings. Activities are ongoing to further develop the HNL test for eventual implementation in routine clinical practice.

“In various studies, HNL has demonstrated superior performance compared to biomarkers currently used to diagnose bacterial infection,” said Per Venge, CEO of P&M Venge AB. “I am therefore very excited that we have been able to successfully demonstrate the detection of HNL on the Minicare I-20 using blood samples from patients with upper respiratory tract infections in the Uppsala University hospital, where within a few minutes patients with a bacterial infection could clearly be distinguished from those with viral infections or other conditions.”

Based on Philips’ proprietary biosensor technology, the Minicare I-20 handheld diagnostics platform is designed to detect multiple target molecules at very low concentrations in a single ‘finger-prick’ blood sample, and display the results on a handheld analyzer within minutes. Philips already has CE marking for its Minicare I-20 based cardiac troponin I (cTnI) blood test for the rapid point-of-care diagnosis of heart attack, and it is currently developing further tests for acute care settings.

Minicare I-20 is simple and easy to use by non-laboratory staff. The analyzer’s built-in connectivity allows direct transfer of the data to laboratory and hospital information systems to update patient files, while integrated calibration and fail-safe functionalities ensure the robustness and accuracy needed for confident on-the-spot decision making.

Meridian Bioscience, Inc. announced the launch of TruQuick(TM), a comprehensive point-of-care product menu of rapid tests for the diagnosis of tropical, infectious, sexually transmitted, respiratory, gastrointestinal, cancer, and cardiac diseases. This product menu will enable Meridian to rapidly expand its product portfolio of high value rapid tests for its commercial operations in Asia Pacific and other emerging markets around the world.

TruQuick(TM) is a qualitative lateral flow chromatographic immunoassay menu of over 60 products. TruQuick(TM) rapid tests can aid in the diagnosis of infectious pathogens and other important acute diseases in 10 to 20 minutes with high levels of accuracy and speed to results. Meridian understands the clinical testing requirements in Asia and other emerging markets for speed, sensitivity, specificity, and breadth of product line.

Lourdes Weltzien, Ph.D., President of Meridian Asia Pacific commented, "We are excited to launch the new TruQuick(TM) brand of rapid tests for the rapidly growing point-of-care market in the Asia Pacific region. As for other regions of the world, Meridian will quickly introduce the TruQuick(TM) brand of products based on regional demands and registration priorities."

Richard L. Eberly, President, Chief Commercial Officer, stated, "One of Meridian`s key strategies over the past few years has been to expand our global commercial operations in emerging markets around the world. Meridian has expanded operations in China, Singapore, Australia, Africa, and South America. The product portfolio for these emerging markets is rapidly expanding. We are delighted to add the TruQuick(TM) brand of rapid point-of-care products to our commercial channels in these important markets."

GenePOC, Inc. (GenePOC) a member of the Debiopharm Group is proud to announce that it has started the commercialization of its first two CE-IVD marked tests, GenePOC™ CDiff and GenePOC™ GBS assays on the revogene™ platform that recently obtained CE-IVD marking. In addition to the distribution partners across all major markets in Europe announced earlier, distribution agreements have been signed with Sedeer Medical, Headquarters in Qatar , and Bühlmann Laboratories in Switzerland . GenePOC has today commercial reach across Europe and the Middle East for the commercialization of its first products. This is a key milestone in the evolution of GenePOC's commercial operations.

"The GenePOC CDiff test will fulfill the increasing market need for affordable, fully automated and easy to use testing at Point of Care as early detection of C. difficile can lead to better control and management of the infection, which in turn can improve patient health, reduce the risk of transmission, and potentially lower mortality and morbidity", Patrice Allibert CEO of GenePOC commented. "We are also delighted to start our commercialization with the signing of these additional collaborations. We have seen first-hand the enthusiasm of our partners during our first distributors' meeting in Q4 of 2016 and in recent pre-launch interactions. We expect the combination of exceptional products and partners to lead to rapid adoption of the revogene™ platform", he continued.

The commercial partners signed up today are Astra Formedic S.r.l. in Italy , bestbion dx GmbH in Germany /Austria, Biosynex Group in France, EMM Life Science AB in Sweden/ Denmark / Finland /Nor-way/ Iceland , Fannin Ltd in Ireland , Mediphos Group BV in Netherlands / Belgium / Luxembourg , Near Patient Diagnostics Ltd in the UK, Vitro S.A.B. de C.V. in Spain / Portugal , Sedeer Medical direct or through partners in Qatar , Iran , United Arab Emirates , Bahrain , Kuwait and Oman , and Bühlmann Laboratories in Switzerland . Negotiations are ongoing for those countries not listed yet and GenePOC expects to sign on additional distributors in the coming months to best serve customers initially in the EMEA region and later in the year globally.

Researchers from the Institute of Physical Chemistry of the Polish Academy of Sciences, or IPC PAS, in Warsaw, Poland, have developed a new method to quickly identify potential life-threatening bacteria within a matter of minutes.

The procedure utilizes luminescent magnetic microparticles, which are coated with selected bacteriophages to quickly identify potential bacterial species in patients.

Current methods to identify bacterial infections take several days while samples are taken to see if bacteria grow in a petri dish in a laboratory.

"Faster, better, cheaper - we managed to achieve all of these objectives," Dr. Jan Paczesny, who led the research project, said in a press release. "This can be seen by any interested party as, in full awareness, we relinquished patent protection."

Researchers used a flow cytometer, a simple and inexpensive device used in blood tests, to identify bacteria. A sample is passed through the cytometer via a narrow nozzle that forces larger particles, such as cells, to travel through one by one. The stream flowing through the cytometer is lit by lasers and uses detectors to record the light reflected from individual particles.

In order to easily label the bacteria to be intercepted and identified, researchers created special bioconjugates, or complexes formed by combining microparticles with biomolecules. The biological element to do this was bacteriophage, or a virus infecting a particular species of bacteria.

The bacteriophages were combined with microparticles that could emit light to easily be registered on the cytometer along with showing magnetic properties.

"We started by searching for inexpensive, commercially available microparticles that met our requirements," Marta Janczuk-Richter, Ph.D. student, said in a press release. "It turned out that appropriate particles were already available on the market - and exactly the ones we were looking for. Their surface was covered with just those chemical functional groups we needed to place virtually any type of bacteriaphage on them."

Researchers found that several bioconjugates attach to each bacteria allowing for the detection of a single bacterium. This procedure could easily be adapted by hospitals to test for a variety of bacteria.

PathogenDx and Emerald Scientific have announced that the companies have entered into a distribution agreement for the PDx-C test kits, the latest technology in microbial testing. Emerald Scientific is the leading provider of supplies and support to cannabis testing labs throughout the United States. The PathogenDx product line enables Emerald Scientific clients to test cannabis flower, extract, and infused products for E.coli, Salmonella, and Aspergillus simultaneously in six hours or less. The combination of Pathogen Dx technology and manufacturing with Emerald's distribution reach and customer support provides the cannabis industry with the most rapid and cost effective method to procure PDx technology.

The PDx technology provides the only DNA-based test that can detect for multiple pathogens simultaneously. The increased throughput enables cannabis producers to more rapidly move product through the supply chain. Milan Patel, PathogenDx CEO, commented, "This agreement is ground breaking for PathogenDx because it combines the unmatched reach of Emerald Scientific with the PathogenDx technology allowing each to leverage the strengths of each company." Emerald Scientific will officially release the PDx-C kits at the Emerald Conference on February 2nd and 3rd in San Diego. "The Emerald Conference is the premier scientific cannabis conference, showcasing the latest scientific products in the industry, so it really provides us with an excellent opportunity to present this new technology," said Kirsten Blake, Director of Sales and Business Development for Emerald Scientific.

Dr. Carl Yamashiro, VP for Product Development, stated that this is the first of a number of products to be released for PathogenDx, which will be coming to the market during 2017. Products include testing for pathogens in food, agriculture and water.

Informant Plus was designed to protect facilities, inventories and personnel by providing manufacturers, warehouses, distribution centers and shipping companies an immediate screening method for microscopic concentrations of toxigenic and allergenic mold spores which could adversely affect their investments and business assets. Mold can grow almost anywhere that is damp and warm, and once it contaminates a facility, it can permeate throughout, resulting in a multitude of other problems, as well as the destruction of products. The costs and inconvenience required to isolate and exterminate these contagions can easily spiral out of control.

Offering facility management teams a usable and deployable tool, Informant Plus is a mature, military-grade technology that yields an extremely accurate result. The system is the only product on the market that produces results within 15 minutes, without the need for an expensive and often time-consuming laboratory analysis.

"When mold is present in a commercial enterprise, time to an actionable decision is money," said Tim Scherkenback, general manager of AdVnt Biotechnologies. "The Informant Plus system protects businesses with a quick turn-around solution only AdVnt can provide by allowing decisions to be made in minutes versus hours or days. We have eliminated the need for petri dishes, contractors and complicated processes, allowing your company's personnel to use the product effectively to save money. Informant Plus is 'Detection Made Simple' so your facility management teams can make the most informed and efficient first-response decision for your company, as well as your clients and shareholders."

Capable of detecting pathogenic and allergenic mold spores, Informant Plus is designed to military specifications. The test is based on an immunochromatographic assay.

ZeptoMetrix Corporation and FIND are pleased to announce the first commercially available malaria Plasmodium falciparum culture panels with standard concentrations of histidine rich protein 2 (HRP2).

The ZeptoMetrix Malaria P. falciparum culture panels, which are available in a range of concentrations from six different malaria strains, are intended for use by researchers and manufacturers to develop new high sensitivity malaria rapid diagnostic tests.

HRP2 is the antigen used in most malaria rapid diagnostic tests to detect P. falciparum. By providing a range of standard HRP2 concentrations, including some that are very low, the panel can be used to evaluate the diagnostic sensitivity of improved tests that are in development.

Malaria rapid diagnostic tests have played an important role in malaria control in recent years, enabling health care workers to quickly diagnose and treat malarial fevers, particularly in young children. There were an estimated 212 million cases of malaria and 429 000 related deaths in 2015, according to the World Health Organization's 2016 World Malaria Report, with some 70% of reported deaths occurring in children under the age of five.

Thanks to intensified interventions to prevent, diagnose and treat malaria, incidence of the disease decreased by an estimated 41% globally between 2000 and 2015, and by 21% between 2010 and 2015. Global malaria targets for 2030 include the reduction of malaria incidence and mortality by at least 90% compared to 2015 levels. Reaching these ambitious targets will require new, more sensitive rapid diagnostic tests to detect asymptomatic malaria infections.

"Global concerns with regards to malaria remain exceptionally high," Dr. Gregory R. Chiklis, President and CEO of ZeptoMetrix, relayed to his company. "We are extremely proud and pleased to be able to partner directly with FIND to help support our industry with the additional tools necessary to assist in R&D."

Hema Diagnostic Systems, located in Miramar, Florida, USA, a wholly owned subsidiary of Generex Biotechnology Corporation, has announced its intention to develop a new and novel multiplex assay designed for use with Sepsis. Given the preliminary designation of RAPID 1-2-3® HEMA® SEPSIS, the team development is coordinated effort involving both Hema Diagnostic Systems and Generex Biotechnology.

Sepsis is a complex clinical syndrome of inflammatory dysregulation in response to infection. It is found primarily in hospital settings and is a major cause of disease and death in the United States and worldwide. Over 1 million people every year are afflicted by this syndrome in the US alone. It has been estimated that between 28-50% of these patients die (National Center for Health Statistics Data Brief No. 62 June 2011. Inpatient care for septicemia or sepsis: a challenge for patients and hospitals).

Sepsis is a rapidly-developing life-threatening condition and a leading cause of hospital deaths in the US and abroad. Early assessment and management is the key to improving survival rates. Because of the rapid development and progression of sepsis, there is an unmet clinical need for a diagnostic test that will allow physicians to accurately assess at patient's status in a matter of minutes.

Using its proprietary diagnostic platform, HDS is developing a quantitative, multiplex, rapid point-of-care diagnostic assay for direct bedside use by physicians and medical personnel to evaluate a patient's current status within the sepsis syndrome. The results of this assay will be available in 15-20 minutes.

This multiplex assay will be a rapid result diagnostic tool providing physicians with quantifiable biomarker based data to assess and monitor a patient's current status and likelihood of progression within sepsis syndromes. As such, it is a multi-purpose diagnostic assay.

This assay will be based on the detection of biomarkers, usually proteins, which are normally produced in the body under sepsis conditions. The detection of multiple biomarkers in sepsis patients and their quantitation will also allow the physician to closely monitor the development of the sepsis syndrome in real-time, to aid in determining the overall effects of treatment choices, and to alter treatment, if necessary.

Chembio Diagnostics, Inc. (CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, announced that it has received a CE mark for its DPP® HIV-Syphilis combination assay. The Chembio DPP® HIV-Syphilis Assay is now cleared to be marketed and sold within the member states of the European Union and the Caribbean region, except for Puerto Rico.

The Chembio DPP® HIV-Syphilis Assay is a single-use, rapid screening test for the detection of antibodies to HIV types 1 and 2 and syphilis Treponema pallidum using fingerstick whole blood, venous whole blood, serum, or plasma. The test requires a small 10 µl blood sample, is highly sensitive and specific, provides results in as little as 15 minutes, has a built-in procedural control, can be stored at room temperature, and has up to a 24-month shelf life.

John Sperzel, Chembio's Chief Executive Officer, commented, "We are pleased to receive a CE mark for our DPP® HIV-Syphilis Assay, which allows us to market and sell the test in Europe and the Caribbean region, except for Puerto Rico. We believe the DPP® HIV-Syphilis Assay can play a role in the global initiative to reduce transmission of HIV and syphilis to unborn children, as well as to screen certain populations to address growing HIV and syphilis co-infection rates."

Co-infection rates of HIV and syphilis are on the rise and, according to the Centers for Disease Control and Prevention, there is an estimated two-to-five-fold increased risk of contracting HIV if exposed to that infection when syphilis is present. Further, an estimated two million pregnancies annually are affected by mother-to-child-transmission of HIV and/or syphilis, resulting in high rates of stillbirth, spontaneous abortion, low birth weight and perinatal death. Congenital syphilis is a preventable disease, which could be significantly reduced through effective prenatal screening, and treatment of infected pregnant women.

"We intend to leverage our patented DPP® platform to deliver diagnostic tests that are most needed in each corner of the world. In the U.S., our goal is to bring our DPP® HIV-Syphilis Assay to market as quickly as possible, as there currently are no other such combination tests available in the U.S. market. We plan to complete a U.S. clinical trial for our DPP® HIV-Syphilis Assay and file for U.S. regulatory approval in early 2017. In addition to our receipt of a CE mark for the DPP® HIV-Syphilis Assay, we have previous regulatory approvals in Mexico and Brazil, and we are working to obtain approvals in certain Southeast Asia countries, following our recent acquisition of Malaysia-based RVR Diagnostics,” added Sperzel.